4-(1,4-dioxa-spiro[4.5]dec-8-yl)-cyclohexanone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 September 1996 - 27 November 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

423-860-2

EC Name:

-

Cas Number:

56309-94-5

Molecular formula:

Hill formula: C14H22O3 CAS formula: C14H22O3

IUPAC Name:

4-{1,4-dioxaspiro[4.5]decan-8-yl}cyclohexan-1-one

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

HsdCpb: WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: males: 184 - 208 g, females: 158 - 166 g
- Fasting period before study: from about 17 hours before dosing up to 4 hours after treatment
- Housing: individual
- Diet: ad libitum, except for fasting period
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23°C
- Humidity (%): 40 - 63%
- Air changes (per hr): not specified
- Photoperiod: 12 hours light / 12 hours dark

IN-LIFE DATES: From: To: 10 October 1996 - 24 October 1996

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqu. methocel K4M Premium solution

Remarks:

hydroxypropyl methylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle: 20 mL/kg
- Justification for choice of vehicle: not specified

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

Doses:

2000 mg(kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: behaviour and general condition were monitored for at least 6 hours after administration and the daily, body weight was determined before treatment and on days 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Males: number of deaths: 0
Females: number of deaths: 0

Clinical signs:

other: 1 - 15 min post application: retention of feces, abdominal position, disturbed movements and dyspnoae were observed, which persisted up to 2 days.

Gross pathology:

no organ alterations

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 in rats was determined to be > 2000 mg/kg bw.

Executive summary:

The test item was tested for acute toxicity in rats after oral administration of 2000 mg/kg bw to 5 male and 5 female animals.

Signs of intoxication (retention of feces, abdominal position, locomotor disturbance and dyspnea) were seen 1 - 15 minutes after treatment and lasted up to day 2.

The gross pathological examination revealed no organ alterations.

The median lethal dose (LD50) after an observation period of 15 days is > 2000 mg/kg bw.